Evaluation of Pulmonary Doppler Signals in Patients With Systemic Sclerosis(SSc)

NCT02278445 | Withdrawn

• 1 other identifier: DOP22_3
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Doppler signals can be recorded from the lung parenchyma by means of a pulsed Doppler ultrasound system incorporating a special signal processing package- the Transthoracic Parametric Doppler (TPD) (Echosense Ltd., Haifa, Israel). Systemic sclerosis patients often develop pulmonary vascular disease leading to pulmonary hypertension. The TPD system may provide important insight into pulmonary blood vessels characteristics by the LDS (Lung Doppler Signals) signals that are related to pulmonary hypertension. The TPD performance in detecting PAH in SSc patients will be assessed in the study.

Conditions

Systemic Sclerosis; Pulmonary Hypertension

Keywords

Systemic Sclerosis; Pulmonary hypertension; Lung Doppler Signals

Outcome Measures

Primary Outcomes (1)

• Number of SSc patients correctly identified with pulmonary hypertension severity in each of the 4 defined groups by RHC.

  Analyze Doppler data of 4 SSc groups (according to pulmonary hypertension severity) resulting in typical features. The features will be implemented in a pre-determined diagnostic algorithm that will determine the overall statistical success of the method in comparison to RHC data.

  12 month

Study Arms (1)

Doppler ultrasound

EXPERIMENTAL

Recording Doppler ultrasound noninvasively from the right chest wall

Radiation: Doppler ultrasound; Device: Transthoracic Parametric Doppler (TPD) (Echosense Ltd., Haifa, Israel)

Interventions

Doppler ultrasound RADIATION

Recording Doppler ultrasound noninvasively from the right chest wall

Doppler ultrasound

Transthoracic Parametric Doppler (TPD) (Echosense Ltd., Haifa, Israel) DEVICE

Doppler ultrasound

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able and willing to give signed informed consent prior to enrollment
• Male or female, ≥ 18 years of age
• Diagnosis of SSc according to 2013 ACR/EULAR SSc Classification Criteria (van den Hoogen 2013): Score ≥ 9.
• Patients with RHC data available from measurement within 3 weeks prior to TPD assessment
• No change in or initiation of PAH specific therapy between the last RHC and TPD

You may not qualify if:

• People unable or unwilling to give informed consent.
• PCWP or LVEDP \> 15 mmHg
• Any PH etiology outside Group 1 (Dana Point, 2008)
• Pregnant women
• Patients having severe chest wall deformity

Sponsors & Collaborators

• Echosense Ltd.: lead

Study Sites (1)

Sheba Medical Center, Pulmonology department

Ramat Gan, Israel

Location

MeSH Terms

Conditions

Scleroderma, Systemic; Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Merav Lidar, Dr

  Sheba medical center, Rheumatology department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2014
• First Posted: October 30, 2014
• Study Start: November 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 2, 2015

Record last verified: 2014-08

Locations

IL (1)